Infusion pump systems and methods

ABSTRACT

Some embodiments of an infusion pump system can include a controller in which one or more features sets to be provided by the controller are enabled or disabled based upon the particular pump device that is connected to the controller. For example, in some embodiments, one or more advanced features of the controller are available to the user only when a first type of pump device (e.g., having predefined settings stored therein) is connected to the controller, and those advanced features of the controller are disabled when a second type of pump device is connected to the controller.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This is a continuation of U.S. patent application Ser. No. 14/819,929filed on Aug. 6, 2015, which is a continuation of U.S. patentapplication Ser. No. 13/760,596 filed on Feb. 6, 2013 (now U.S. Pat. No.9,132,234), which is a continuation of U.S. patent application Ser. No.13/049,588 filed on Mar. 16, 2011 (now U.S. Pat. No. 8,454,581), theentire contents of this previous application being incorporated hereinby reference.

TECHNICAL FIELD

This document relates to a portable infusion pump system, such as awearable insulin pump system that delivers dosages of a medication to auser over an extended period of time.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump may be used todeliver a medicine to a patient as part of a medical treatment. Themedicine that is delivered by the infusion pump can depend on thecondition of the patient and the desired treatment plan. For example,infusion pumps have been used to deliver insulin to diabetes patients soas to regulate blood-glucose levels. In another example, infusion pumpshave been used to deliver pain medication to patients suffering fromchronic or degenerative conditions so as to reduce pain symptoms andincrease comfort.

In some circumstances, the infusion pumps can be equipped with userinterface components, internal circuitry and components that offeradditional feature sets to the user. For example, some infusion pumpsare configured for delivery of insulin can be equipped with circuitryand communication devices that provide additional features sets such aswireless interaction with continuous glucose monitoring (CGM) sensors orwireless interaction with blood glucose meters. Some of these infusionpumps may be configured in a manner so that these additional featuresets are generally enabled at all times.

SUMMARY

Some embodiments of an infusion pump system can include a controller inwhich one or more features sets to be provided by the controller areenabled or disabled based upon the particular pump device that isconnected to the controller. For example, the controller can beconfigured to removably attach with any one of a plurality of pumpdevices having different pump settings (e.g., set by the supplier), andthe controller may enable particular features of the controller when afirst type of pump device is attached therewith or may disable thoseparticular features of the controller when a second type of pump deviceis attached therewith. Thus, in some embodiments, one or more advancedfeatures of the controller are available to the user only when a firsttype of pump device (e.g., having predefined settings stored therein) isconnected to the controller, and those advanced features of thecontroller are disabled when a second type of pump device is connectedto the controller.

In particular embodiments, a portable infusion pump system may include apump device and a controller device. The pump device may include a pumphousing that defines a space to receive a medicine and a drive system todispense the medicine from the pump device when the medicine is receivedin the space of the pump housing. The controller device may be removablyattachable to the pump device so as to electrically connect with thepump device and control dispensation of the medicine from the pumpdevice. The controller device may automatically disable a first featureset provided by the controller device in response to electricalconnection with the pump device.

Some embodiments described herein include a method of using a portableinfusion pump system. The method may include removably attaching a pumpdevice to a controller device to form an electrical connecting betweenthe controller device and the pump device so that the controller deviceis operable to control dispensation of medicine from the pump device.The controller device may automatically disable an advanced feature setprovided by the controller device in response to electrical connectionwith the pump device. The method may also include operating a userinterface of the controller device.

Other embodiments may include a method of controlling a portableinfusion pump system. The method may include querying a pump device todetermine if the pump device is a first type of pump device or a secondtype of pump device. The pump device may be removably attached to acontroller device to form an electrical connecting between thecontroller device and the pump device so that the controller device isoperable to control dispensation of medicine from the pump device. Themethod may also include automatically disabling a first feature setprovided by the controller device in response to the controller devicerecognizing that the pump device is the second type of pump device.

In some embodiments, a portable infusion pump system may include a pumpdevice and a controller device. The pump device may include a pumphousing that defines a space to receive a medicine and a drive system todispense the medicine from the pump device when the medicine is receivedin the space of the pump housing. The controller device may be removablyattachable to the pump device so as to electrically connect with thepump device and control dispensation of the medicine from the pumpdevice. The controller device may be configured to automatically enablea first feature set provided by the controller device in response to thecontroller device recognizing that the pump device is a first type ofpump device. Also, the controller device may be configured toautomatically disable the first feature set provided by the controllerdevice in response to the controller device recognizing that the pumpdevice is a second type of pump device.

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of the infusionpump system may include a configuration in which one or more advancedfeatures of a controller device are automatically activated or madeavailable to the user only in response to a particular type of pumpdevice being connected to the controller device. Also, the controllerdevice may disable the advanced features in the event that a second typeof pump device is connected to the controller device.

Second, is certain embodiments, the controller device of the infusionpump system can be configured to removably attach with any one ofplurality of different types of pump devices. In such circumstances, thecontroller device may be configured as a reusable controller that isrepeatedly used with a series of disposable pump devices over anextended period of time.

Third, in some embodiments, each of the different types of pump devicescan include a selected setting (e.g., stored in a memory device) that isestablished by the supplier so as to define the type of pump device. Insuch circumstances, the supplier can dictate which pump devices willenable additional feature sets of the controller device and which otherpump devices will disable the additional feature sets of the controllerdevice.

Fourth, using techniques discussed herein, some embodiments of thecontroller device may automatically activate advanced features relatedto CGM (e.g., wireless communication with a continuous glucose sensor,user interface display of CGM data, and the like) only in response to anadvanced type of pump device being connected to the controller device.For example, the advanced type of pump device may include a parametersetting stored in an internal memory device that is detected by thecontroller device, which in turn causes the controller device to makeavailable to the user the advanced feature set related to CGM.Conversely, the controller device may disable advanced features relatedto CGM in response to a basic type of pump device being connected to thecontroller device. In this example, the basic type of pump device mayinclude a different parameter setting stored in an internal memorydevice that is detected by the controller device, which in turn causesthe controller device to remove availability of the advanced feature setrelated to CGM (e.g., disable the wireless communication device toincrease battery life, provide reduced user interface options and menus,and the like).

Fifth, some embodiments of the controller device may automaticallyactivate advanced features related to communication with a blood glucosemeter (e.g., wireless communication with a blood test strip reader,advanced bolus calculation options, and the like) only in response to anadvanced type of pump device being connected to the controller device.In these embodiments, the controller device may disable advancedfeatures related to communication with a blood glucose meter in responseto a basic type of pump device being connected to the controller device.In this example, the basic type of pump device may include a differentparameter setting stored in an internal memory device that is detectedby the controller device, which in turn causes the controller device toremove availability of the advanced feature set related to communicationwith a blood glucose meter.

Sixth, some embodiments of the controller device may automaticallyactivate a feature set related to a “training mode” only in response toa training type of pump device being connected to the controller device.The feature set related to the training mode may permit a new user topractice using the infusion pump system (e.g., setting dosage programs,responding to alarms, and the like) without actually receiving medicinedispensation from the infusion pump system or with delivering medicinein accordance with a basic dosage schedule. For example, the trainingtype of pump device may include a parameter setting stored in aninternal memory device that is detected by the controller device, whichin turn causes the controller device to make available to a set of basicmenu options that train the user to use the infusion pump system whilethe drive system is disabled (e.g., no medication is delivered) or whilethe drive system delivers medicine in accordance with a basic dosageschedule. In these embodiments, the controller device may disable thefeatures related to the training mode and enable other features in whichthe pump system is activated to deliver medicine (e.g., operate in anormal mode with multiple basal profile options and bolus deliveryoptions) in response to a different type of pump device being connectedto the controller device.

Sixth, some embodiments of the controller device may automaticallyactivate selected features related to a first medicine type (e.g., auser interface and dosage options related to insulin delivery) only inresponse to a first type of pump device being connected to thecontroller device. For example, the first type of pump device mayinclude a medicine type parameter stored in an internal memory devicethat is detected by the controller device, which in turn causes thecontroller device to make available to the user the specific userinterface and dosage options related to insulin delivery. Conversely,the controller device may disable selected features related to insulindelivery in response to a second type of pump device being connected tothe controller device. In this example, the second type of pump devicemay include a different medicine type parameter setting stored in aninternal memory device that is detected by the controller device, whichin turn causes the controller device to remove availability of theselected features related to insulin delivery and instead activatedifferent user interface and dosage options related to a differentmedicine. Thus, the controller can be configured to control dosages ofmultiple different types of medicines, and the controller's userinterface and dosage options can be automatically adjusted based uponthe particular type of pump device that is connected therewith.

The details of one or more embodiments are set forth in the accompanyingdrawings and the description below. Other features, objects, andadvantages will be apparent from the description and drawings, and fromthe claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system in accordancewith some embodiments.

FIG. 2 is a flow chart of a process for using an infusion pump system inaccordance with some embodiments.

FIG. 3 is a perspective view of the infusion pump system of FIG. 1 in adetached state.

FIG. 4 is a perspective view of the infusion pump system of FIG. 1 in anattached state.

FIGS. 5-6 are perspective views of the pump device of FIGS. 1 and 3being discarded and the controller device of FIGS. 1 and 3 being reusedwith a new pump device.

FIG. 7 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 8 is an exploded perspective view of a pump device for an infusionpump system, in accordance with some embodiments.

FIG. 9 is an exploded perspective view of an infusion pump systemincluding a controller device that provides different feature sets inresponse to connection with a particular type of pump device, inaccordance with some embodiments.

FIG. 10 is a flow chart of a process for using the infusion pump systemof FIG. 9, in accordance with some embodiments.

FIG. 11 is an exploded perspective view of an infusion pump systemincluding a controller device that provides different feature sets inresponse to connection with a particular type of pump device, inaccordance with some embodiments.

FIG. 12 is a flow chart of a process for using the infusion pump systemof FIG. 11, in accordance with some embodiments.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, an infusion pump system 10 can include a pumpdevice 100 and a controller device 200 that communicates with the pumpdevice 100. The pump device 100 in this embodiment includes a housingstructure 110 that defines a cavity 116 in which a fluid cartridge 120can be received. The fluid cartridge 120 may contain insulin or anothermedicine as described in more detail below. The pump device 100 also caninclude a cap device 130 to retain the fluid cartridge 120 in the cavity116 of the housing structure 110. The pump device 100 can include adrive system 300 (described in connection with FIG. 8) that advances aplunger 125 in the fluid cartridge 120 so as to dispense fluidtherefrom. The controller device 200 communicates with the pump device100 to control the operation of the drive system. When the controllerdevice 200, the pump device 100 (including the cap device 130), and thefluid cartridge 120 are assembled together, the user can (in someembodiments) conveniently wear the infusion pump system 10 on the user'sskin under clothing, in a pouch clipped at the waist (e.g., similar to acell phone pouch), or in the user's pocket while receiving the fluiddispensed from the pump device 100.

Still referring to FIG. 1, the controller device 200 may be configuredas a reusable component that provides electronics and a user interfaceto control the operation of the pump device 100. In such circumstances,the pump device 100 can be a disposable component that is disposed ofafter a single use. For example, as described in more detail below inconnection with FIGS. 4-5, the pump device 100 can be a “one time use”component that is recycled or otherwise discarded after the fluidcartridge 120 therein is exhausted. Thereafter, the user can removablyattach a new pump device 100′ (having a new medicine cartridge 120′) tothe reusable controller device 200 for the dispensation of fluid from anew fluid cartridge 120′. Accordingly, the user is permitted to reusethe controller device 200 (which may include complex or valuableelectronics, as well as a rechargeable battery) while disposing of therelatively low-cost pump device 100 after each use. Such a pump system10 can provide enhanced user safety as a new pump device 100′ (and drivesystem therein) is employed with each new fluid cartridge 120′.

The controller device 200 may be equipped with control circuitry 240(described in connection with FIG. 7) that is programmed to offer anumber of feature sets to the user. The different features sets may beimplemented, for example, in the user interface components of thecontroller device 200, in one or more wireless communication componentshoused in the controller device 200, in one or more sensors housed inthe controller device 200, and the like. The controller device 200 canbe configured to enable or disable selected feature sets based upon theparticular pump device 100 that is removably attached to the controllerdevice 200 to form an electrical connection. In one example as shown inthe embodiment in FIG. 1, the controller device 200 can be configured toprovide a feature set related to continuous glucose monitoring (CGM) sothat the controller device 200 communicate with a wireless glucosesensor device 260. In this example, the controller device 200 may housea wireless communication device 255 that is configured to wirelesslycommunicate with a communication device 265 of the wireless glucosesensor device 260. The wireless glucose sensor device 260 may include amain body portion that is adhered to a skin surface while a subcutaneoussensor shaft penetrates through the skin to detect the user's bloodglucose level. Further, a user interface 220 of the controller device200 can display the user's glucose level 226 after data from thewireless glucose sensor device 260 is communicated to the controllerdevice 200. In this embodiment, these features related to CGM areautomatically enabled in response to the controller device 200 beingconnected with a first type of pump device 100, and the controllerdevice 200 may automatically disable these features related to CGM if asecond type of pump device 100 is attached to the controller device 200.The type of pump device can be defined, for example, by a parametersetting stored in an internal circuit 115 housed in the pump device 100(e.g., internally stored on an internal memory chip, an identificationcircuit, or the like). This parameter setting may be a permanent settingthat is established by the supplier. Thus, in some embodiments asdescribed in more detail below in connection with FIGS. 9-12, one ormore advanced features of controller device 200 may be enabled for theuser only when a first type of pump device (e.g., the pump device 100having a first type of parameter setting) is connected to the controllerdevice 200. In such circumstances, those advanced features of thecontroller device 200 may be automatically disabled when a second typeof pump device (e.g., the pump device 100 having a second type ofparameter setting) is connected to the controller device 200.

Still referring to FIG. 1, the pump system 10 can be a medical infusionpump system that is configured to controllably dispense a medicine fromthe cartridge 120. As such, the fluid cartridge 120 can contain amedicine 126 to be infused into the tissue or vasculature of a targetedindividual, such as a human or animal patient. For example, the pumpdevice 100 can be adapted to receive a medicine cartridge 120 in theform of a carpule that is preloaded with medicine suitable fordispensation via a portable infusion system, such as insulin, anothermedicine for use in the treatment of Diabetes (e.g., Byetta®, Symlin®,or others), a pain relief medicine (e.g., morphine, oxycodone, or thelike), an antibiotic medication (e.g., Metronidazole, Penicillin, or thelike), a pre-term labor medication, a hormone therapy medication, ablood pressure medication, an anti-emetic medication, an osteoporosismedication, antiviral drugs, anti-inflammatory drugs, antibodies,chemotherapy treatments, anti-cancer drugs (e.g., interferonor or thelike), or another injectable medicine. Such a cartridge 120 may besupplied, for example, by Eli Lilly and Co. of Indianapolis, Ind. Thefluid cartridge 120 may have other configurations. For example, in someembodiments the fluid cartridge 120 may comprise a reservoir that isfixedly built into the pump housing structure 110.

In some embodiments, the pump device 100 can include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, the pump housing structure 110 can include one or more retainerwings (not shown in FIG. 1) that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. Such a configuration mayfacilitate the “one-time-use” feature of the pump device 100. In someembodiments, the retainer wings can interfere with attempts to removethe medicine cartridge 120 from the pump device 100, thus ensuring thatthe pump device 100 will be discarded along with the medicine cartridge120 after the medicine cartridge 120 is emptied, expired, or otherwiseexhausted. Accordingly, the pump device 100 can operate in atamper-resistant and safe manner because the pump device 100 can bedesigned with a predetermined life expectancy (e.g., the “one-time-use”feature in which the pump device is discarded after the medicinecartridge 120 is emptied, expired, or otherwise exhausted).

Still referring to FIG. 1, the controller device 200 can be removablyattached to the pump device 100 so that the two components aremechanically mounted to one another in a fixed relationship. Such amechanical mounting can form an electrical connection between theremovable controller device 200 and the pump device 100. For example,the controller device 200 can be in electrical communication with aportion of a drive system 300 (FIG. 8) of the pump device 100. Asdescribed in more detail below, the pump device 100 can include a drivesystem that causes controlled dispensation of the medicine or otherfluid from the cartridge 120. In some embodiments, the drive systemincrementally advances a piston rod (not shown in FIG. 1) longitudinallyinto the cartridge 120 so that the fluid is forced out of an output end122. A septum 121 (FIG. 1) at the output end 122 of the fluid cartridge120 can be pierced to permit fluid outflow when the cap device 130 isconnected to the pump housing structure 110. For example, the cap devicemay include a penetration needle (not shown in FIG. 1) that puncturesthe septum 121 during attachment of the cap device 130 to the housingstructure 110. Thus, when the pump device 100 and the controller device200 are attached and thereby electrically connected, the controllerdevice 200 communicates electronic control signals via ahardwire-connection (e.g., electrical contacts or the like) to one ormore internal components of the pump device 100 so that drive system 300is urged to dispense medicine from the cartridge 120. Thus, in responseto the electrical control signals from the controller device 200, thedrive system of the pump device 100 causes medicine to incrementallydispense from the medicine cartridge 120. Power signals, such as signalsfrom the rechargeable battery 245 of the controller device 200 and fromthe charger battery 345 of the pump device 100 may also be passedbetween the controller device 200 and the pump device 100.

As shown in FIG. 1, the pump device 100 can include an electricalconnector 118 (e.g., having conductive pads, pins, and the like) that isexposed to the controller device 200 and that mates with a complementaryelectrical connector (refer to connector 218 in FIG. 3) on the adjacentface of the controller device 200. The electrical connectors 118 and 218provide the electrical communication between the control circuitry 240(refer, for example, to FIG. 7) housed in the controller device 200 andat least a portion of the drive system or other components of the pumpdevice 100. For example, in some embodiments, the electrical connectors118 and 218 can permit the transmission of electrical control signals tothe pump device 100 and the reception of feedback signals (e.g., sensorsignals) from particular components within the pump device 100. Theelectrical connectors 118 and 218 may similarly facilitate transmissionof one or more power signals from the rechargeable battery pack 245 tothe pump device 100, where the signals may be used to provide power tocomponents of the pump device 100, or to transmit one or more powersignals from the charger battery 345 to the controller device, where thesignals may be used to recharge the rechargeable battery 245 or to powercomponents of the controller device 200.

Still referring to FIG. 1, the controller device 200 can include theuser interface 220 that permits a user to monitor the operation of thepump device 100. In some embodiments, the user interface 220 can includea display device 222 and one or more user-selectable buttons (e.g.,several buttons 224 are shown in the embodiment of FIG. 1). The displaydevice 222 can include an active area in which numerals, text, symbols,images, or a combination thereof can be displayed. For example, thedisplay device 222 can be used to communicate a number of settings ormenu options for the infusion pump system 10. In this embodiment, theuser may press one or more of the buttons to shuffle through a number ofmenus or program screens that show particular settings and data (e.g.,review data that shows the medicine dispensing rate, the total amount ofmedicine dispensed in a given time period, the amount of medicinescheduled to be dispensed at a particular time or date, the approximateamount of medicine remaining in the cartridge 120, or the like). In someembodiments, the user can adjust the settings or otherwise program thecontroller device 200 by pressing one or more buttons of the userinterface 220. For example, in embodiments of the infusion pump system10 configured to dispense insulin, the user may press one or more of thebuttons to change the dispensation rate of insulin or to request that abolus of insulin be dispensed immediately or at a scheduled, later time.In some implementations, the display device 222 may also be used tocommunicate information regarding remaining battery life, the user'srecently detected blood glucose level, and the like.

Accordingly, in some embodiment, when the controller device 200 isconnected to the pump device 100, the user can be provided with theopportunity to readily monitor the infusion pump operation by simplyviewing the user interface 220 of the controller device 200 connected tothe pump device 100. Such monitoring capabilities may provide comfort toa user who may have urgent questions about the current operation of thepump device 100. Also, in these embodiments, there may be no need forthe user to carry and operate a separate module to monitor the operationof the infusion pump device 100, thereby simplifying the monitoringprocess and reducing the number of devices that must be carried by theuser. If a need arises in which the user desires to monitor theoperation of the pump device 100 or to adjust the settings of the pumpsystem 10 (e.g., to request a bolus amount of medicine), the user canreadily operate the user interface 220 of the controller device 200,which is removably attached to the pump device 100, without therequirement of locating and operating a separate, wireless controlmodule.

Referring now to FIG. 2, some embodiments of the infusion pump system 10can be used in a process 400 wherein the controller device 200 enablesor disables selected feature sets based upon the particular pump device100 that is connected to the controller device 200. As previouslydescribed, the controller device 200 may be equipped with controlcircuitry 240 (described in connection with FIG. 7) that is programmedto offer a number of feature sets to the user (e.g., feature sets thatfacilitate CGM capabilities, capabilities for wireless communicationwith a blood glucose meter device, training mode capabilities,alternative user interface options depending on medicine to bedispensed, and the like). The different features sets may beimplemented, for example, in the user interface components of thecontroller device 200, in one or more wireless communication componentshoused in the controller device 200, in one or more sensors housed inthe controller device 200, and the like. In this example process 400,the operation 410 can be performed to provide an electrical connectionbetween the pump device 100 and the controller device 200. For example,the electrical connection can be provided when the controller device 200electrically communicates via the connectors 118 and 218 (FIGS. 1 and3). In operation 420, the controller device 200 may query the pumpdevice to determine which type of pump device is connected to thecontroller device 200. For example, as described in more detail below,the pump device 100 may include a parameter setting stored in aninternal circuit 115 housed in the pump device 100 (e.g., internallystored on an internal memory chip, an identification circuit, or thelike). This parameter setting may be a permanent setting that isestablished by the supplier. In some embodiments, all of the pumpdevices 100 are physically similar, and only the parameter settingselected by the supplier defines which type of pump device will becommunicated to the controller device 200.

If the controller device 200 determines in operation 430 that theconnected pump device 100 is a first type of pump device 100 (e.g., aparameter setting of “1”), the process 400 continues to operation 440.In operation 440, the controller device 200 may automatically (e.g.,without manual intervention by the user) enable a first advanced featureset provided by the controller device 200. For example, if thecontroller device 200 is programmed to provide CGM capabilities, thecontroller device 200 may automatically activate the wirelesscommunication device 255 (FIG. 1) and activate the “Glucose Level”output 226 (FIG. 1) on the user interface display 222. In operation 450,the controller device 200 can output an alert indicative that the firstadvanced feature set is enabled. For example, the alert message 225(FIG. 1) can be output to notify the user of the activation of theadvanced capabilities.

Still referring to FIG. 2, if the controller device 200 determines inoperation 430 that the connected pump device 100 is not a first type ofpump device 100 (e.g., a parameter setting different than “1”), theprocess 400 continues to operation 460. In operation 460, the controllerdevice 200 may automatically (e.g., without manual intervention by theuser) disable the first advanced feature set provided by the controllerdevice 200. For example, if the controller device 200 is programmed toprovide CGM capabilities, the controller device 200 may disable thewireless communication device 255 (FIG. 1) and prevent display of the“Glucose Level” output 226 (FIG. 1). In doing so, the battery life ofthe controller device 200 may be extended because the advancedcomponents are not activated to draw power from the battery. Inoperation 470, the controller device 200 can output an alert indicativethat the first advanced feature set is disabled. For example, thecontroller device 200 may display an alert message to notify the user ofthat the advanced capabilities and not activated until a different typeof pump is connected to the controller device 200. Thus, the process 400may be implemented so that one or more advanced features of controllerdevice 200 are enabled for the user when a first type of pump device(e.g., the pump device 100 having a first type of parameter setting) isconnected to the controller device 200. Also, those advanced features ofthe controller device 200 may be automatically disabled when a secondtype of pump device (e.g., the pump device 100 having a second type ofparameter setting) is connected to the controller device 200.

Referring now to FIG. 3, the controller device 200 can be removablyattached to the pump device 100 during operation of the infusion pumpsystem 10 to dispense medicine. For example, the pump device 100 may bemoved in a longitudinal direction toward the controller device 200 untilthe complementary features connect and secure the separate components inthe side-by-side arrangement. Moreover, in some embodiments, the pumpdevice 100 and controller device 200 can be readily attached togetherwith a “one-movement” process that is convenient to the user.

The controller device 200 can include a controller housing structure 210having a number of features that are configured to mate withcomplementary features of the pump housing structure 110 so as to form areleasable mechanical connection. For example, the pump housingstructure 110 can include a barrel 111 that mates with a complementarybarrel channel 211 of the controller housing 210. Also, the pump housing110 may include a protrusion 113 that mates with a spring-biased latch213 of the controller housing 210, and the pump housing 110 may furtherinclude grooves 114 that mate with a tongue structure 214 of thecontroller housing 110 so as to provide longitudinal guided motionduring the attachment process. In various implementations, the pumpdevice 100 and the controller device 200 can be mounted to one anotherso that the assembled system 10 is resistant to water migration bothinto the pump housing structure 110 and the controller housing structure210. For example, a gasket seal around the electrical connector 118 canprovide water-resistant protection for the electrical connection betweenthe pump device 100 and the controller device 200. Thus, the sensitiveinternal components in the controller device 200 and the pump device 100can be reliably protected from water migration if the user encounterswater (e.g., rain, incidental splashing, and the like) while using thepump system 10.

Referring to FIG. 4, the infusion pump system 10 can be configured to beportable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump system 10 on the user's skin (e.g.,skin adhesive) underneath the user's clothing or carry the pump device100 in the user's pocket (or other portable location) while receivingthe medicine dispensed from the pump device 100. The pump system 10 isshown in FIG. 4 as being held in a user's hand 5 so as to illustrate anexemplary size of the system 10 in accordance with some embodiments.This embodiment of the infusion pump system 10 is compact so that theuser can wear the portable infusion pump system 10 (e.g., in the user'spocket, connected to a belt clip, adhered to the user's skin, or thelike) without the need for carrying and operating a separate module. Insuch embodiments, the cap device 130 of the pump device 100 can beconfigured to mate with an infusion set 146. In general, the infusionset 146 can be a tubing system that connects the infusion pump system 10to the tissue or vasculature of the user (e.g., to deliver medicine intothe tissue or vasculature under the user's skin). The infusion set 146can include a flexible tube 147 that extends from the pump device 100 toa subcutaneous cannula 149 that may be retained by a skin adhesive patch(not shown) that secures the subcutaneous cannula 149 to the infusionsite. The skin adhesive patch can retain the infusion cannula 149 influid communication with the tissue or vasculature of the patient sothat the medicine dispensed through the tube 147 passes through thecannula 149 and into the user's body. The cap device 130 can providefluid communication between the output end 122 (FIG. 1) of the medicinecartridge 120 and the tube 147 of the infusion set 146.

In some embodiments, the infusion pump system 10 can be pocket-sized sothat the pump device 100 and controller device 200 can be worn in theuser's pocket or in another portion of the user's clothing. In somecircumstances, the user may desire to wear the pump system 10 in a morediscrete manner. Accordingly, the user can pass the tube 147 from thepocket, under the user's clothing, and to the infusion site where theadhesive patch can be positioned. As such, the pump system 10 can beused to deliver medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner.

In some alternative embodiments, the infusion pump system 10 can beconfigured to adhere to the user's skin directly at the location inwhich the skin is penetrated for medicine infusion. For example, a rearsurface 102 (FIG. 3) of the pump device 100 can include a skin adhesivepatch so that the pump device 100 can be physically adhered to the skinof the user at a particular location. In these embodiments, the capdevice 130 can have a configuration in which medicine passes directlyfrom the cap device 130 into an infusion cannula 149 that is penetratedinto the user's skin. In some examples, the user can temporarily detachthe controller device 200 (while the pump device 100 remains adhered tothe skin) so as to view and interact with the user interface 220.

Referring now to FIGS. 5-6, the infusion pump system 10 can be operatedsuch that the pump device 100 is a disposable, non-reusable componentwhile the controller device 200 is a reusable component. In thesecircumstances, the pump device 100 may be configured as a “one-time-use”device that is discarded after the medicine cartridge is emptied,expired, or otherwise exhausted. Thus, in some embodiments, the pumpdevice 100 can be designed to have an expected operational life of about1 day to about 30 days, about 1 day to about 20 days, about 1 to about14 days, or about 1 day to about 7 days—depending on the volume ofmedicine in the cartridge 120, the dispensation patterns that areselected for the individual user, and other factors. For example, amedicine cartridge 120 containing insulin can have an expected usagelife of about 7 days after the cartridge is removed from a refrigeratedstate and the septum 121 is punctured. In some circumstances, thedispensation pattern selected by the user can cause the insulin to beemptied from the medicine cartridge 120 before the 7-day period. If theinsulin is not emptied from the medicine cartridge 120 after the 7-dayperiod, the remaining insulin can become expired sometime thereafter. Ineither case, the pump device 100 and the medicine cartridge 120 thereincan be discarded after exhaustion of the medicine cartridge 120 (e.g.,after being emptied, expired, or otherwise not available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, the rechargeable battery pack245, and other components that may have relatively higher manufacturingcosts can be reused over a longer period of time. For example, in someembodiments, the controller device 200 can be designed to have anexpected operational life of about 1 year to about 7 years, about 2years to about 6 years, or about 3 years to about 5 years—depending on anumber of factors including the usage conditions for the individualuser. Accordingly, the user can be permitted to reuse the controllerdevice 200 (which can include complex or valuable electronics, and arechargeable battery pack) while disposing of the relatively low-costpump device 100 after each use. Such a pump system 10 can provideenhanced user safety as a new pump device 100′ (and drive systemtherein) is employed with each new fluid cartridge 120′.

Referring to FIGS. 5-6, the same controller device 200 can be reusedwith a new pump device 100′ having a new medicine cartridge 120′retained therein, and the previously used pump device 100, including theexhausted medicine cartridge, can be discarded in a discard bin 20. Thenew pump device 100′ (FIG. 4) can have a similar appearance, formfactor, and operation as the previously used pump device 100, and thusthe new pump device 100′ can be readily attached to the controllerdevice 200 for controlled dispensation of medicine from the new medicinecartridge 120′. Each time a new pump device 100′ is connected to thecontroller device 200, the controller device 200 may query the pumpdevice 100 to determine which type of pump is being connected (asdescribed, for example, in the process 400 of FIG. 2). In someembodiments, the user can prepare the new pump device 100′ for use withthe controller device 200. For example, the user may insert the newmedicine cartridge 120′ in the cavity 116 of the new pump device 100′and then join the cap device 130 to the pump housing to retain the newmedicine cartridge 120′ therein (refer, for example, to FIG. 1).Although the tubing 147 of the infusion set 146 is not shown in FIG. 4,it should be understood that the tubing 147 can be attached to the capdevice 130 prior to the cap device 130 being joined with the housing110. For example, a new infusion set 146 can be connected to the capdevice 130 so that the tubing 147 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller device 200)before attaching the infusion set patch to the user's skin. As shown inFIG. 4, the new medicine cartridge 120′ may be filled with medicine suchthat the plunger 125 is not viewable through the barrel 111.

The new pump device 100′ can be removably attached to the controllerdevice 200 to assemble into the infusion pump system 10 for delivery ofmedicine to the user. As previously described, the guided motion in thelongitudinal direction 219 provides the user with a convenient“one-movement” process to attach the pump device 100′ and the controllerdevice 200. For example, the user can readily slide the pump device 100′and the controller device 200 toward one another in a single movement(e.g., in the longitudinal direction 219) that causes both a physicalconnection and an electrical connection. Thus, the infusion pump system10 can permit users to readily join the pump device 100′ and thecontroller device 200 without compound or otherwise difficult handmovements—a feature that can be beneficial to child users or to elderlyusers.

Referring now to FIG. 7, the controller device 200 (shown in an explodedview) houses a number of components that can be reused with a series ofsuccessive pump devices 100. In particular, the controller device 200can include control circuitry 240 and rechargeable battery pack 245,each arranged in the controller housing 210. As described above,rechargeable battery pack 245 may provide electrical energy tocomponents of control circuitry 240, other components of the controllerdevice (e.g., a display device 222 and other user interface components,sensors, or the like), or components of the pump device 100. Controllercircuitry 240 may be configured to communicate control signals tocomponents of the pump device 100 (e.g., so as to activate the drivesystem), or to receive power or feedback signals from the pump device100. In some embodiments, the control circuitry 240 can be implementedas one or more printed circuit boards having a number of electroniccomponents mounted thereto. It should be understood that although thecontrol circuitry 240 is depicted as comprising one or more printedcircuit boards, the control circuitry 240 can have other forms,including a flexible circuit substrate and other configurations.

Still referring to FIG. 7, the user interface 220 of the controllerdevice 200 can include input components and/or output components thatare electrically connected to the control circuitry 240. For example,the user interface 220 can include the display device 222 having anactive area that outputs information to a user and buttons 224 that theuser can use to provide input. Here, the display device 222 can be usedto communicate a number of settings or menu options for the infusionpump system 10. In some embodiments, the controller circuitry 240 canreceive input commands from a user's button selections and thereby causethe display device 222 to output a number of menus or program screensthat show particular settings and data (e.g., review data that shows themedicine dispensing rate, the total amount of medicine dispensed in agiven time period, the amount of medicine scheduled to be dispensed at aparticular time or date, the approximate amount of medicine remainingthe cartridge 120, the amount of battery life remaining, or the like).As previously described, the control circuitry 240 can be programmableby user to change any one of a number of settings for the infusion pumpsystem 10. For example, the user may provide one or more instructions toadjust a number of basal dosage settings or bolus options for theoperation of the infusion pump system 10. Such settings may be stored inthe memory devices arranged in the controller circuitry 240. Thecontroller circuitry 240 can include other components, such as sensors,that are electrically connected to the circuit board.

Some embodiments of the controller circuitry 240 can include a cableconnector (e.g., a USB connection port or another data cable port) thatis accessible on an external portion of the controller housing 210. Assuch, a cable can be connected to the controller circuitry 240 to uploaddata or program settings to the controller circuitry 240 or to downloaddata from the controller circuitry 240. For example, historical data ofmedicine delivery can be downloaded from the controller circuitry 240(via the cable connector) to a computer system of a physician or a userfor purposes of analysis and program adjustments. Optionally, the datacable can also provide recharging power.

Still referring to FIG. 7, a perspective view of portions of controllercircuitry 240 and the rechargeable battery pack 245 is shown.Rechargeable battery pack 245 may include one or more lithium-ion orlithium-polymer battery cells, and the rechargeable battery pack 245 canbe coupled to one or the circuit boards housed in the controller device200. In some implementations, the lithium-ion or lithium-polymer battery500 may be a 3.8 volt battery. The rechargeable battery pack 245 caninclude a high-current-output battery that is capable of discharging abrief current burst to power, for example, the drive system 300 of thepump device 100, and can also provide energy sources for variouselectronic components of the infusion pump system 10. Alternativeembodiments of the rechargeable battery 245 can include a combination ofbatteries and capacitors. The rechargeable battery 245 may be capable ofaccepting and storing electrical energy over time (e.g., “tricklecharge”). For example, the rechargeable battery 245 can be charged withenergy supplied from a pump power source 345 (FIG. 8), according to someimplementations. The rechargeable battery 245 can receive electricalenergy from the pump power source 345 housed in the pump device 100(e.g., the charger battery 345), from a plug-in wall charger, from acable connector (e.g., a USB connection port that is connected to thecontroller circuitry 240), or from another charging device (e.g., acharging cradle), according to some implementations.

Accordingly, the infusion pump system 10 can include two power sources345 and 245—one arranged in the disposable pump device 100 and anotherarranged in the reusable controller device 200—which can permit a userto continually operate the controller device 200 without having torecharge a battery via a plug-in wall charger or other cable. Becausethe controller device 200 can be reusable with a number of pump devices100 (e.g., attach the new pump device 100′ after the previous pumpdevice 100 is expended and disposed), the rechargeable battery 245 inthe controller device can be recharged over a period of time, each timewhen a new pump device 100′ is connected thereto. Such a configurationcan be advantageous in those embodiments where the pump device 100 isconfigured to be a disposable, one-time-use device that attaches to areusable controller device 200. For example, in those embodiments, the“disposable” pump devices 100 recharges the rechargeable battery 245 inthe “reusable” controller device 200, thereby reducing or possiblyeliminating the need for separate recharging of the controller device200 via a power cord plugged into a wall outlet.

Still referring to FIG. 7, a main processor 242 can be mounted to one ofthe circuit boards of the control circuitry 240 housed in the controllerdevice 200. In various implementations, processor 242 may comprise oneor more microprocessors, microcontrollers, digital signal processors,instantiated cores within one or more programmable logic devices (e.g.,application specific integrated circuit, field programmable gate array,complex programmable logic device), or the like. Processor 242 mayexecute instructions and perform tasks associated with the infusion pumpsystem. For example, the processor 242 may coordinate the electricalcommunication to and/or from the controller device 200 (e.g.,communication between the controller device 200 and the pump device100). Processor 242 may receive inputs indicative of various statusesrelating to the infusion pump system. For example, the processor 242 mayreceive one or more inputs that indicate the type of pump device that isconnected to the controller device 200, the activated/deactivated statusof the wireless communication device 255, the charge status of therechargeable battery 245, or the like.

In various implementations, processor 242 executes instructions storedin memory locations internal of the processor 242 or in memory locationsin one or more memory devices external of the processor 242. Forexample, in some embodiments the processor 242 may include on-boardrandom access memory (RAM), where instructions may be loaded andexecuted therefrom by the processor 242. Processor 242 may also includevarious forms of on-board non-volatile memory for storing instructionsor data in some implementations, including but not limited to EPROM,EEPROM, Flash, and the like. In some embodiments, memory devicesexternal of the processor 242 are used. A memory device 243 may storeinstructions, data, or both, for use by the processor 242. In someimplementations, memory device includes FRAM data storage. Memory device242 may store user settings and alarms, as well as parameters for theinfusion pump system 10, including last-used pump parameters. It shouldbe understood from the description herein that the circuit boardconfiguration of the control circuitry 240 can be selected so as tomodify the location of the processor 242, memory devices 243,rechargeable battery 245, and the wireless communication device 255within the controller housing 210.

Referring now to FIG. 8, in some embodiments, the pump device 100 caninclude a power source 345, referred to above as a charger battery. Insome embodiments, the power source 345 is an alkaline battery cell, suchas a 1.5 Volt “AAA” alkaline battery cell. The power source 345 may becapable of transmitting electrical energy to the controller device 200when the pump device 100 is attached to the controller device 200, viaconnectors 118 and 218 as described above. For example, the power source345 may be used to recharge the rechargeable battery pack 245 when thepump device 100 is attached to the controller device 200. In someembodiments, the power source 345 is used to provide energy to the drivesystem 300 of the pump device 100, and also to electronic components ofthe controller device 200. In some circumstances, the power source 345may provide the energy to power all aspects of the infusion pump system10. In some circumstances, the rechargeable battery 245 may provide theenergy to power all aspects of the infusion pump system 10. In somecircumstances, the rechargeable battery 245 and the power source 345(charger battery) may each be responsible for powering particularaspects of the infusion pump system 10. In some circumstances, therechargeable battery 245 may provide the energy to supplement the energyprovided by the power source 345 to power aspects of the infusion pumpsystem.

The pump device 100 can include the drive system 300 that is controlledby the controller device 200. The drive system 300 can accurately andincrementally dispense fluid from the pump device 100 in a controlledmanner. In this embodiment, the drive system 300 includes anelectrically powered actuator 310 (e.g., a rotational motor), a gearsystem 320, a ratchet mechanism 330 that incrementally rotates a gearwheel 350, and a threaded piston rod 370 that is urged toward to theplunger 125 of the medicine cartridge 120. The pump device 100 caninclude a connector circuit to facilitate the transfer of signals to andfrom the electrical connector 118. In some implementations, theconnector circuit in the pump device 100 can include internal circuit115 (e.g., an internal memory chip, an identification circuit, or thelike). The internal circuit 115 can be used to store the parametersetting that defines which type of pump device will be communicated tothe controller device 200. This parameter setting may be a permanentsetting that is established by the supplier. The internal circuit 115may also store data regarding the pump device 100 and its operationalhistory. As previously described, the electrical connector 118 of thepump device 100 can mate with the connector 218 (FIG. 2) of thecontroller device 200 so that electrical communication can occur betweenthe pump device 100 and the controller device 200. In some embodiments,the connection can operate as a passageway for the control signals (fromthe controller circuitry 240 of the controller device 200) transmittedto the drive system 300 or other components of the pump device 100.

Referring now to FIG. 9, some embodiments of the controller device 200can be configured to automatically enable or disable particular featuresto be provided by the controller in response to a connection with aparticular type of pump device 100. As previously described, thecontroller device 200 in this embodiment is equipped with the controlcircuitry 240 that is programmed to offer a number of different featuresets to the user. The different features sets may be implemented, forexample, in the user interface 220 of the controller device 200, in oneor more wireless communication components 255 housed in the controllerdevice 200, in one or more sensors or electronic components housed inthe controller device 200, or a combination thereof. Thus, eachcontroller device 200 can be configured to connect with severaldifferent types of pump devices 100. The particular type of pump device100 can be defined by an electronic indicator, for example, a parametersetting stored in the internal circuit 115 housed in the pump device 100(e.g., internally stored on an internal memory chip, an identificationcircuit, or the like). This parameter setting may be a permanent settingthat is established by the supplier. In particular embodiments, thedifferent types of pump devices 100 can have substantially the sameshape, size, and mechanical configuration, so the different types ofpump devices 100 are different from one another only in the parametersetting stored in the internal circuit 115.

It should be understood from the description herein that the electronicindicator that is used to at least partially define the type of pumpdevice may have a form other than the parameter setting stored in theinternal circuit 115. For example, in alternative embodiments, theparticular type of pump device 100 can be defined by connecting a seriesof pins of the electrical connector 118 to different voltage levels (Lowor high). In such embodiments, the electrical connector 118 of the pumpdevice 100 can include three designated connector pins to define eight(2×2×2=8) different types of the pump devices that are readilyrecognized by the controller device 200 when the controller connector218 mates with the pump connector 118. In a second example of analternative embodiment, the particular type of pump device 100 can bedefined by a resistor value in a circuit coupled to the electricalconnector 118 of the pump body. For instance, the resistor value of aparticular resistor (or series of resistors) mounted in the pump device100 can cause a switch of the control circuitry 240 to be shifted to a“closed” state or “open” state in response to the controller connector218 connecting with the pump connector 118. In a third example of analternative embodiment, the particular type of pump device 100 can bedefined by the absence or presence of a light reflecting surface withinthe pump device 100. For example, the controller device 200 can beequipped with a light emitter and light receiver that are positionedadjacent to the pump device 100 when the pump device 100 and controllerdevice 200 are removably attached. As such, the light emitter can emit alight beam that is reflected from the light reflecting surface of afirst type of pump device 100 and returns to the light receiver, therebyallowing the controller to recognize that the first type of pump device100 is attached to the controller device 200. Conversely, the lightemitter can emit a light beam that is not reflected from the second typeof pump device (which is lacking the light reflecting surface) so thatlittle or no light returns to the light receiver, thereby allowing thecontroller to recognize that the second type of pump device 100 isattached to the controller device 200. In a fourth example of analternative embodiment, the particular type of pump device 100 can bedefined by the absence or presence of a magnet housed in the pumphousing 110 at a predetermined position. In such embodiments, thecontroller device 200 can be equipped with a magnetic sensor (e.g., aHall effect sensor, an induction coil, or the like) that indicateswhether the pump device 100 is a first type (having the magnet housedtherein) or a second type (not having the magnet housed therein). In afifth example of an alternative embodiment, the particular type of pumpdevice 100 can be defined by the presence or absence (or a particulartype) of an RFID (radio frequency identification) chip housed in thepump housing 110 at a predetermined position. In such embodiments, thecontroller device 200 can be equipped with an RFID sensor that detectsthe presence or absence (or the particular type) of the RFID chip of thepump device 100. The RFID sensor can be coupled to the control circuitry240 so as to indicates which type of pump device 100 is connected to thecontroller device 200.

Still referring to FIG. 9, some embodiments of the controller device 200can be configured to provide a first feature set related to CGM, asecond feature set related to wireless communication with a bloodglucose meter (e.g., a blood test strip reader), a third feature setrelated to training mode options (e.g., for new users), and a basicfeature set to provide basal and bolus infusion options. Some or all ofthese feature sets can be automatically enabled or disabled by thecontroller device 200 in response to a connection with a particular typeof pump device. In one example, if the pump device 100 is a first typeof pump (e.g., a parameter setting of pump type “1”), the controllerdevice 200 is configured to automatically activate the feature setrelated to CGM in response to the controller device 200 being connectedwith the first type of pump device 100. In such circumstances, thecontroller device 200 may activate the wireless communication device 255that is configured to wirelessly communicate with the communicationdevice 265 of the wireless glucose sensor device 260. Further, the userinterface 220 of the controller device 200 can continuously display theuser's glucose level 226 after data from the wireless glucose sensordevice 260 is communicated to the controller device 200. Also, the userinterface 220 of the controller device 200 may display CGM menu optionsand may output an alert to notify the user that the advanced featuresare now enabled. Optionally, the controller device 200 may also enablewireless communication with blood glucose meter 270 (described below) inresponse to a connection with the first type of pump device 100. In suchcircumstances, the first type of pump device 100 may be referred to asan advanced pump device that triggers the activation of some or all ofthe advanced feature sets provided by the controller device 200.

In a second example, if the pump device 100 is a second type of pump(e.g., a parameter setting of pump type “2”), the controller device 200is configured to automatically activate the feature set related towireless communication with the blood glucose meter 270 in response tothe controller device 200 being connected with the second type of pumpdevice 100. In such circumstances, the controller device 200 mayactivate the wireless communication device 255 that is configured towirelessly communicate with the wireless communication device 275 of theglucose meter 270. Further, the user interface 220 of the controllerdevice 200 can display a prompt for the user to synchronized with theglucose meter 270 (“Sync Now” option), which then leads the user tocalculate a bolus in response to receiving the wireless data from theglucose meter 270. Also, the user interface 220 of the controller device200 may display glucose meter menu options and may output an alert tonotify the user that the glucose meter communication feature are nowenabled. In particular embodiments, the user interface 220 of thecontroller device 200 may output an alert to notify the user that thefeatures related to CGM will be disabled until a first type of pump isconnected with the controller. The controller device 200 mayautomatically disable the features related to CGM when a second type ofpump device 100 is connected thereto so as to conserve the controllerresources and battery power.

In a third example, if the pump device 100 is a third type of pump(e.g., a parameter setting of pump type “3”), the controller device 200is configured to automatically activate the feature set related to atraining mode in response to the controller device 200 being connectedwith the third type of pump device 100. In such circumstances, thecontroller device 200 may activate the user interface to providesimplified or reduced menu options to the user. For example, when thecontroller device 200 enables the training mode feature set, the dosageoptions available to the user via the user interface 220 may be limitedto a selected subset of basal profiles (e.g., a basic basal deliveryprofile with three time segments in a 24-hour period) and may be limitedto basic bolus options (e.g., single meal bolus profiles without optionsfor a timed bolus or a combo bolus). As such, the training mode featureset can assist a new user in learning to operate the pump system 10without inadvertently selecting complex medicine delivery options. Insome embodiments, when the controller device 200 enables the trainingmode feature set, the pump device 100 may dispense the medicine inaccordance with the selected basal and bolus delivery options. Inalternative embodiments, when the controller device 200 enables thetraining mode feature set, the controller device 200 may disable pumpdrive control signals to the pump device 100 so that no medicine isdispensed (because the drive system is not advanced forward). In suchembodiments, the training mode feature set would be understood as anearly training tool before the user elects to begin pumping. In thewireless communication device 255 that is configured to wirelesslycommunicate with the wireless communication device 275 of the glucosemeter 270. The user interface 220 of the controller device 200 mayoutput an alert to notify the user that the training mode feature set isnow enabled in response to connection with the third type of pump device100. In particular embodiments, the user interface 220 of the controllerdevice 200 may output an alert to notify the user that other advancedfeatures (e.g., features related to CGM, features related to wirelesscommunication with a glucose meter, features related to advanced basaland bolus options, and the like) will be disabled until a different typeof pump is connected with the controller device 200.

In a fourth example, if the pump device 100 is a fourth type of pump(e.g., a parameter setting of pump type “4”), the controller device 200is configured to automatically activate the feature set related to basicpumping operations in response to the controller device 200 beingconnected with the fourth type of pump device 100. In suchcircumstances, the controller device 200 may activate the user interface220 to provide a full set of basal and bolus delivery options while moreadvanced features (e.g., features related to CGM, features related towireless communication with a glucose meter, and the like) are disabled.The user interface 220 of the controller device 200 may output an alertto notify the user that the basic pumping features are now enabled. Inparticular embodiments, the user interface 220 of the controller device200 may output an alert to notify the user that the advanced features(e.g., features related to CGM, features related to wirelesscommunication with a glucose meter, and the like) will be disabled untila first type of pump is connected with the controller. The controllerdevice 200 may automatically disable the features related to wirelesscommunication when a fourth type of pump device 100 is connected theretoso as to conserve the controller resources and battery power.

Referring now to FIG. 10, some embodiments of the infusion pump system10 can be used in a process 500 wherein the controller device 200 isconfigured to connect with three or more different types of pump devices110. For example, as described in connection with FIG. 9, the controllerdevice 200 can enable or disable selected feature sets in response to aconnection with any one of four different types of pump device 100. Inthis process 500, the controller device 200 may be equipped with controlcircuitry 240 (described in connection with FIG. 7) that is programmedto offer a number of feature sets to the user, and the differentfeatures sets may be implemented, for example, in the user interfacecomponents of the controller device 200, in one or more wirelesscommunication components housed in the controller device 200, in one ormore sensors or electronic components housed in the controller device200, and the like. In this example process 500, the operation 510 can beperformed to by the controller device 200 to query the pump device 100to determine which type of pump device is connected to the controllerdevice 200. For example, as previously described in connection with FIG.9, the pump device 100 may include an electronic indicator (e.g., aparameter setting stored in an internal circuit 115 housed in the pumpdevice 100) that is detected by the control circuitry 240 in response toconnection between the pump device 100 and the controller device 200.

If the controller device 200 determines in operation 515 that theconnected pump device 100 is a first type of pump device 100 (e.g., aparameter setting of “1”), the process 500 continues to operation 520.In operation 520, the controller device 200 may automatically (e.g.,without manual intervention by the user) enable a first advanced featureset related to CGM capabilities. For example, the controller device 200may automatically activate the wireless communication device 255(FIG. 1) and activate the “Glucose Level” output 226 (FIG. 1) on theuser interface display 222. As previously described, the controllerdevice 200 may optionally output an alert indicative that this advancedfeature set related to CGM is enabled.

Still referring to FIG. 10, if the controller device 200 determines inoperation 525 that the connected pump device 100 is a second type ofpump device 100 (e.g., a parameter setting of “2”), the process 500continues to operation 530. In operation 530, the controller device 200may automatically enable a second advanced feature set related towireless communication with a glucose meter 270 (FIG. 9). For example,the controller device 200 may automatically activate the wirelesscommunication device 255 (FIG. 1) and activate the user interfacedisplay 222 to provide a prompt to the user (FIG. 9). The controllerdevice 200 may optionally output an alert indicative that this featureset related to communication with the glucose meter 270 is enabled.Also, in operation 540, the controller device 200 can output an alertindicative of which features are disabled (e.g., features related toCGM).

If the controller device 200 determines in operation 545 that theconnected pump device 100 is a third type of pump device 100 (e.g., aparameter setting of “3”), the process 500 continues to operation 550.In operation 550, the controller device 200 may automatically enable athird feature set related to training mode options (FIG. 9). Forexample, the controller device 200 may automatically change the userinterface so that the dosage options available to the user via the userinterface 220 are limited to a selected subset of basal profiles (e.g.,a basic basal delivery profile with three time segments in a 24-hourperiod) and are also limited to basic bolus options (e.g., single mealbolus profiles without options for a timed bolus or a combo bolus). Thecontroller device 200 may optionally output an alert indicative that thetraining mode feature set is enabled. Also, in operation 560, thecontroller device 200 can output an alert indicative of which featuresare disabled (e.g., features related to CGM, features related towireless communication with a glucose meter, features related toadvanced basal and bolus options, and the like).

If the controller device 200 determines in operation 545 that theconnected pump device 100 is not a first, second, or third type of pumpdevice 100 (e.g., a fourth type of pump device having a parametersetting of “4”), the process 500 continues to operation 570. Inoperation 570, the controller device 200 may automatically enable theuser interface 220 to provide a full set of basal and bolus deliveryoptions while more advanced features (e.g., features related to CGM,features related to wireless communication with a glucose meter, and thelike) are disabled. The controller device 200 may optionally output analert indicative that the basic pumping features are enabled. Also, inoperation 580, the controller device 200 can output an alert indicativethat all of the advanced feature sets are disabled.

Referring now to FIG. 11, some embodiments of the controller device 200can be configured to automatically enable or disable features related todelivery of particular medicines in response to a connection between thecontroller device and a particular type of pump device 100. Aspreviously described, the controller device 200 in this embodiment isequipped with the control circuitry 240 that is programmed to offer anumber of different feature sets to the user. The different featuressets related to different medicines may be implemented, for example, inthe user interface 220 of the controller device 200 including differentstatus display information, different basal and bolus options, differentcalculator, historical data reporting options, and the like. Thus, eachcontroller device 200 can be configured to connect with severaldifferent types of pump devices 100, such as a first type of pump device10 that receives a first medicine therein and a second type of pumpdevice 10 that receives a second medicine therein. The particular typeof pump device 100 can be defined by an electronic indicator, forexample, a parameter setting stored in the internal circuit 115 housedin the pump device 100 (e.g., internally stored on an internal memorychip, an identification circuit, or the like). As previously described,this parameter setting may be a permanent setting that is established bythe supplier. The pump body 110 may also carry a label, bar code, orother physical indicator that identifies which type of medicine shouldbe inserted into the pump cavity 116. In particular embodiments, thedifferent types of pump devices 100 can have substantially the sameshape and size, so the different types of pump devices 100 may differentfrom one another only in the parameter setting stored in the internalcircuit 115. Alternatively, the different types of pump devices may alsoinclude differently shaped internal cavities 116 (FIG. 1) so that thefirst type of pump device 100 receives a medicine cartridge having adifferent size or shape from a second medicine cartridge to be receivedby a second type of pump device 100.

In this embodiment, the controller device 200 is configured to provide afirst feature set delivery of a first medicine (e.g., insulin), a secondfeature set related to delivery of a second medicine (e.g., morphine),and a third feature set related to delivery of a third medicine. Itshould be understood from the description herein that the controllerdevice 200 can be programmed in advanced to provide different userinterface options that are customized to each particular type ofmedicine. In such circumstances, the controller device 200 can betriggered to automatically (e.g., without manual user intervention)display the designated user interface options in response to attachmentof a particular type of pump device carrying the designated medicine.

In one example, if the pump device 100 is a first type of pump (e.g., aparameter setting of pump type “A”), the controller device 200 isconfigured to automatically activate the feature set related todispensation of insulin in response to the controller device 200 beingconnected with the first type of pump device 100. In such circumstances,the controller device 200 may activate the user interface display 222 toprovide a number of menu options that are customized for delivery ofinsulin. For example, the user interface 220 can provide basal profileoptions and bolus delivery options specifically tailored to thepharmakinetic characteristics of the insulin medication. Likewise, thedisplay screen 222 of the controller device 200 may display insulintreatment information (e.g., insulin basal rate, blood glucose level,etc.) during idle periods when no buttons 224 are actuated. Further, theuser interface 220 of the controller device 200 may output an alert tonotify the user of which type of medicine is prepared for delivery fromthe connected pump device 100.

In a second example, if the pump device 100 is a second type of pump(e.g., a parameter setting of pump type “B”), the controller device 200is configured to automatically activate the feature set related todispensation of a different medication (morphine in this embodiment) inresponse to the controller device 200 being connected with the secondtype of pump device 100. In such circumstances, the controller device200 may activate the user interface display 222 to provide a number ofmenu options that are customized for delivery of the second medication.For example, the user interface 220 can provide basal profile optionsand bolus delivery options specifically tailored to the pharmakineticcharacteristics of the morphine medication. Likewise, the display screen222 of the controller device 200 may display morphine treatmentinformation (e.g., combined dosage amounts, amount of time until nextbolus dosages is available, etc.) during idle periods when no buttons224 are actuated. Also, the user interface 220 of the controller device200 may output an alert to notify the user of which type of medicine isprepared for delivery from the connected pump device 100.

Referring now to FIG. 12, some embodiments of the infusion pump system10 can be used in a process 600 wherein the controller device 200 isconfigured to connect with multiple different types of pump devices 110that contain different medicines, respectively. For example, asdescribed in connection with FIG. 11, the controller device 200 may beequipped with control circuitry 240 (described in connection with FIG.7) that is programmed in advanced to offer a number of different userinterface options customized to different types of particular medicines.In this example process 600, the operation 610 can be performed to bythe controller device 200 to query the pump device 100 to determinewhich type of pump device is connected to the controller device 200. Forexample, as previously described in connection with FIG. 11, the pumpdevice 100 may include an electronic indicator (e.g., a parametersetting stored in an internal circuit 115 housed in the pump device 100)that is detected by the control circuitry 240 in response to connectionbetween the pump device 100 and the controller device 200.

If the controller device 200 determines in operation 620 that theconnected pump device 100 is a first type of pump device 100 (e.g., aparameter setting of “A”), the process 600 continues to operation 630.In operation 630, the controller device 200 may automatically (e.g.,without manual intervention by the user) enable the controller toprovide a feature set specifically for a first type of medicine (insulinin this embodiment). For example, the controller device 200 mayautomatically activate the user interface 220 so as to provide dosageand menu options related to insulin delivery. In operation 640, thecontroller device 200 can output an alert indicative of which type ofmedicine (insulin in this example) is prepared for delivery from theconnected pump device 100.

Still referring to FIG. 10, if the controller device 200 determines inoperation 650 that the connected pump device 100 is a second type ofpump device 100 (e.g., a parameter setting of “B”), the process 600continues to operation 660. In operation 660, the controller device 200may automatically enable the controller to provide a feature setspecifically for a second type of medicine (morphine in thisembodiment). For example, the controller device 200 may automaticallyactivate the user interface 220 so as to provide dosage and menu optionsrelated to morphine delivery. In operation 670, the controller device200 can output an alert indicative of which type of medicine (morphinein this example) is prepared for delivery from the connected pump device100.

If the controller device 200 determines in operation 650 that theconnected pump device 100 is a not a first or second type of pump device100 (e.g., a parameter setting different than “A” or “B”), the process600 continues to operation 680. In operation 680, the controller device200 may automatically enable the user interface 220 to prompt the userto select which type of medicine is installed in the connected pumpdevice 100. For example, the controller device 200 may display an alertthat includes a list of medicine types so that the user can scrollthrough the list on the display 222 and select the proper type ofmedicine. In response to the user's selection, operation 690 can beperformed so that the controller device 200 automatically enables theuser interface to provide a feature set specifically for the selectedtype of medicine. For example, the controller device 200 mayautomatically activate the user interface 220 so as to provide dosageand menu options related to selected medicine.

Accordingly, the some embodiments of the controller device 200 can beconfigured to automatically activate selected features related to afirst medicine type (e.g., a user interface and dosage options relatedto insulin delivery) only in response to a first type of pump devicebeing connected to the controller device. Optionally, the controllerdevice may automatically disable selected features related to insulindelivery in response to a second type of pump device being connected tothe controller device. Thus, the controller can be configured to controldosages of multiple different types of medicines, and the controller'suser interface and dosage options can be automatically adjusted basedupon the particular type of pump device that is connected therewith.

A number of embodiments have been described. Nevertheless, it will beunderstood that various modifications may be made without departing fromthe spirit and scope of this disclosure. For example, the controllerdevice can be configured to automatically enable or disable feature setsother than those specifically illustrated herein, in response toconnection with a particular type of pump device. Accordingly, otherembodiments are within the scope of the following claims.

What is claimed is:
 1. An insulin delivery system, comprising: at leasta first disposable insulin delivery device and at least a seconddisposable insulin delivery device, wherein each of the first and seconddisposable insulin delivery devices each comprise: a fluid cartridgecomprising a plunger at a first end of the fluid cartridge, a septum atthe second end of the fluid cartridge, and insulin medication, a housingthat defines a space to receive the fluid cartridge, and a drive systemconfigured to dispense the insulin medicine from the insulin deliverydevice, wherein the first disposable insulin delivery device is of adifferent type than the second disposable insulin delivery device,wherein the insulin medication in the first disposable insulin deliverydevice is different from the insulin medication in the second disposableinsulin delivery device; a body-worn glucose monitoring device; and acontroller device removably attachable to each of the first and secondinsulin delivery devices, the controller device being adapted todetermine the type of a disposable insulin delivery device secured tothe controller device, the controller device comprising a user interfacedisplay, wherein the controller device is configured to automaticallyenable wireless communication with the body-worn glucose monitoringdevice in response to the controller device being connected to the firstdisposable insulin delivery device and to disable wireless communicationwith the body-worn glucose monitoring device in response to thecontroller being connected to the second disposable insulin deliverydevice, wherein the controller device is configured to display a user'sglucose level when data from the body-worn glucose monitoring device iswirelessly received by the controller device when wireless communicationwith the body-worn glucose monitoring device is enabled, wherein thecontroller device is enabled to provide customized insulin deliveryoptions for each of the first and second disposable insulin deliverydevices tailored to the pharmakinetic characteristics of the insulinmedication in each disposable insulin delivery device, wherein thecontroller device is configured to notify the user of the type ofmedication in the disposable insulin delivery device reversibly attachedto the controller device when the controller device is reversiblyattached to the disposable insulin delivery device.
 2. The system ofclaim 1, wherein the first disposable insulin delivery device and thesecond disposable insulin delivery device are insulin pump devices. 3.The system of claim 2, wherein the controller device forms an electricalconnection with one of the insulin pump devices reversibly connected tothe controller device.
 4. The system of claim 3, wherein the controllerdevice reads a therapy parameter from the insulin pump device connectedto the controller device.
 5. The system of claim 1, wherein the insulinpump devices each comprise a battery.
 6. The system of claim 1, whereinthe controller device forms an electrical connection to each disposableinsulin delivery device when reversibly attached thereto.
 7. The systemof claim 6, wherein each disposable insulin delivery device comprises ameans for indicating the type of disposable insulin delivery device, theindicating means being recognizable by the controller device in responseto the electrical connection.